BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS

    MDR report key: 1082849 · Received July 25, 2008

    Report

    Report Number
    8010047-2008-00131
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 27, 2008
    Report Date
    July 2, 2008
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    LQC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY ELECTED NOT TO RETURN THE UNIT FOR EVAL. AN OLYMPUS SALES REP VISITED THE FACILITY FOLLOWING THE REPORTED EVENT, AND THE FACILITY HAS DECLINED OFFERS TO PROVIDE ADD'L TRAINING ON THIS DEVICE. THE CAUSE OF THE USER'S EXPERIENCE CANNOT BE CONCLUSIVELY DETERMINED. IF ADD'L SIGNIFICANT INFO BECOMES AVAILABLE AT A LATER DATE, A SUPPLEMENTAL REPORT WILL FOLLOW. THIS REPORT IS BEING FILED AS AN MDR IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIO PANCREATOGRAPHY (ERCP), THE USERS CAPTURED A STONE IN THE COMMON BILE DUCT STONE WITH THE BASKET DEVICE, BUT COULD NOT CRUSH THE STONE. THE FACILITY REPORTED THAT THEY THEN ATTEMPTED TO USE THE EMERGENCY HANDLE TO CUT THE WIRE. THE BASKET WIRE REPORTEDLY BROKE NEAR THE INJECTION PORT, RATHER THAN CUTTING THE BASKET AS EXPECTED. THE PT WAS IMMEDIATELY TAKEN TO SURGERY, AND BOTH THE DEVICE AND STONE WERE REMOVED VIA COMMON BILE DUCT EXPLORATION. THE PT IS REPORTEDLY DOING FINE FOLLOWING SURGERY AND HAS BEEN RELEASED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS LITHOCRUSH LQC OLYMPUS MEDICAL SYSTEMS CORPORATION BML-V442QR 76K

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention